Blood treatment apparatus and method

ABSTRACT

A blood treatment apparatus, including a blood treatment unit configured to receive untreated blood and fresh blood treatment fluid, and emit treated blood and used blood treatment fluid, a pair of fluid pumps configured to pass blood treatment fluid through the blood treatment unit, a pair of blood pumps configured to extract untreated blood from a blood source, pass extracted blood through the blood treatment unit and deliver treated blood to a target vessel, each blood pump including a pump chamber and a flexible member separating the pumping chamber into a first blood accumulating container and a second working fluid accumulating container where the flexible member is configured to vary a volume relationship between the first and the second accumulation containers. A control unit and a measuring device are configured to emit a feedback signal indicative of the amount of working fluid received into, or discharged from at least one of the second accumulation containers whereby the pumped mass or volume of working fluid is determined by the control unit at an arbitrary position of the flexible member.

CROSS RELATED APPLICATIONS

This application is the US national phase of international applicationPCT/EP2009/063290 filed 12 Oct. 2009 and claims priority to SwedishPatent Application No. 0802194-1 filed 14 Oct. 2008 and U.S. ProvisionalApplication No. 61/105,052 filed 14 Oct. 2008 which designated the U.S.and the entire contents of each of these applications are herebyincorporated by reference.

THE BACKGROUND OF THE INVENTION AND PRIOR ART

The present invention relates generally to extracorporeal bloodtreatment. More particularly the invention relates to a blood treatmentapparatus according to the preamble of claim 1 and a method according tothe preamble of claim 8.

A conventional blood treatment apparatus, for instance a hemodialysissystem or a hemodiafiltration system, contains a dialysis fluid circuitand a blood circuit. Each circuit is normally associated with at leastone pump for transporting the fluid in question. Traditionally,peristaltic pumps have been used, and here the rotational speed of thepump can serve as a basis for determining the flow through the pump,e.g. in the blood circuit. For reasons of patient security and costefficiency it is further advantageous to avoid including dedicated flowmeters in the blood circuit. Hence, in designs including non-peristalticblood pumps, it may be complicated to measure the blood flow accurately.In fact, also when peristaltic blood pumps are used, the blood flowmeasure derived from the pump speed may be unreliable. For example ifthe inlet pressure to the pump becomes negative (or more precisely inletsuction occurs), the rotational speed is a poor fluid flow indicator.

Hence, it is desirable to enable apparatus designs using other types ofblood pumps than those operating according to a peristaltic principle.However, there is yet no such solution which renders an accurate bloodflow measurement possible, and at the same time avoids the obviousinfection/contamination risks associated with a multiple-use flow meterin the blood circuit. Of course, for cost reasons, any single-use flowmeters cannot be of high-quality type.

SUMMARY OF THE INVENTION

The object of the present invention is therefore to alleviate the aboveproblems, and provide an accurate, uncomplicated andinfection/contamination safe solution for measuring blood flows where astroke volume of a pump of membrane type is selectable.

According to the invention, one object is achieved by the apparatus asinitially described, wherein the flow measurement means is configured todetermine the at least one blood flow parameter based on a differencebetween first and second amounts of blood treatment fluid. The firstamount reflects a quantity of fresh blood treatment fluid received intothe apparatus comprising the blood treatment unit, the second amountreflects a quantity of used blood treatment fluid emitted from theapparatus, and both amounts are registered during a first well-definedperiod of operation of the apparatus. The at least one blood flowparameter reflects an average blood flow during a second well-definedperiod.

The proposed blood treatment apparatus is advantageous because itprovides accurate flow measures into as well as out from a bloodtreatment device while offering high design flexibility in terms of theblood pump characteristics.

According to one embodiment of the invention, it is presumed that theapparatus is configured to operate according to a cyclic process. Duringa first phase, the untreated blood is extracted from the blood source,and during a second phase, the treated blood is delivered to the targetvessel. Here, the first well-defined period represents the time requiredto complete one of the first and second phases (i.e. either the first orthe second phase) at least once, and the second well-defined periodrepresents an interval during which both the first and second phases arecompleted at least once. Thereby, the flow measurement can be updatedrepeatedly in a convenient manner.

According to another embodiment of the invention, the fluid pumps areconfigured to control the operation of the blood pumps via the bloodtreatment fluid. This is desirable because thereby a compact, costefficient and comparatively reliable apparatus design is attainable.

According to yet another embodiment of the invention, the apparatusinstead includes means for controlling the blood pumps via other meansthan the blood treatment fluid, such as an incompressible working fluidseparated from the blood treatment fluid, or by mechanical means (e.g.in the form of piston pumps). Here, the flow measurement means isconfigured to determine the flow parameter on the further basis of arespective stroke volume of the blood pumps. This design isadvantageous, since it renders it straightforward to determine variousprocess parameters, such as ultrafiltration. Furthermore, piston pumpsare desirable, since here, by keeping track of the piston position, itis possible to determine a pumped volume at arbitrary pump positions,i.e. not only at the end positions for the pistons.

According to still another embodiment of the invention, a firstparameter of the at least one blood flow parameter reflects a flow ofblood into the blood treatment unit. Here, the first well-defined periodof operation represents a duration of the first phase, and the secondwell-defined period represents the duration of the first phase plus theduration of one second phase temporally adjoining the first phase (i.e.a phase of the cyclic process which either follows directly subsequentto the first phase, or a phase immediately preceding the first phase).Thereby, an accurate measure of the blood flow into the blood treatmentdevice can be determined.

According to another embodiment of the invention, as an alternative or acomplement to the above-mentioned first parameter, a second parameter ofthe at least one blood flow parameters reflects a flow of blood out fromthe blood treatment unit. Here, the first well-defined period ofoperation instead represents a duration of the second phase of thecyclic process. However, again, the second well-defined periodrepresents the duration of the second phase plus the duration of onefirst phase temporally adjoining the second phase. Hence, an accuratemeasure of the blood flow exiting from the blood treatment device can bedetermined.

According to a further embodiment of the invention, the blood treatmentunit includes a semi-permeable membrane structure, e.g. represented by amultitude of hollow fibers whose walls constitute a respectivesemi-permeable membrane. The blood is being passed on a blood side ofsaid structure, say inside the fibers, and the blood treatment fluid isbeing passed on a fluid side of said structure, say outside the fibers.Moreover, the apparatus includes means configured to determine anultrafiltration parameter between the blood and the fluid sides of saidstructure based on a difference between the first and second amounts ofblood treatment fluid. Thus, the blood cleaning process can becontrolled more accurately.

According to another aspect of the invention, the object is achieved bythe method described initially, the following steps are executed: duringa first well-defined period a first amount of fresh blood treatmentfluid received into the apparatus comprising the blood treatment unit isregistered. A second amount of used blood treatment fluid emitted fromthe apparatus is also registered during the first well-defined period.Then, after expiry of a second well-defined period, the at least oneblood flow parameter is determined as an average blood flow during thesecond well-defined period. The at least one blood flow parameter isderived based on a difference between the first and second amounts.

According to a further aspect of the invention, the object is achievedby a computer program, which is loadable into the memory of a computer,and includes software adapted to control the method proposed above whensaid program is run on a computer.

According to another aspect of the invention the object is achieved by acomputer readable medium, having a program recorded thereon, where theprogram is to control a computer to perform the method proposed abovewhen the program is loaded into the computer.

Clearly, the invention is applicable to blood flow measurements inrespect of dual-needle implementations. However, the proposed solutionis advantageous also for blood treatment apparatuses for executingsingle-needle hemodialysis or hemodiafiltration, i.e. where the bloodsource and the target vessel represent the same point of contact with apatient. Further advantages, beneficial features and applications of thepresent invention will be apparent from the following description andthe dependent claims.

BRIEF DESCRIPTION OF THE DRAWINGS AND TABLE

The present invention is now to be explained more closely by means ofembodiments, which are disclosed as examples, and with reference to theattached drawings and table.

Table 1 shows first and second phases of a proposed cyclic treatmentprocess, first and second well-defined periods during which fluidamounts are registered to determine blood flow values and illustratesthe temporal relationships there between;

FIGS. 1 a-b show block diagrams over a blood treatment apparatusaccording to a first embodiment of the invention during first and secondphases respectively of the cyclic treatment process;

FIGS. 2 a-b show block diagrams over a blood treatment apparatusaccording to a second embodiment of the invention during first andsecond phases respectively of the cyclic treatment process;

FIGS. 3 a-b show block diagrams over a blood treatment apparatusaccording to a third embodiment of the invention during first and secondphases respectively of the cyclic treatment process;

FIGS. 4 a-b show block diagrams over a blood treatment apparatusaccording to a fourth embodiment of the invention during first andsecond phases respectively of the cyclic treatment process; and

FIG. 5 illustrates, by means of a flow diagram, a general method ofmeasuring a blood flow parameter according to the invention.

DESCRIPTION OF EMBODIMENTS OF THE INVENTION

We refer initially to FIG. 1 a, which shows a block diagram over a bloodtreatment apparatus (e.g. a dialysis apparatus) according to a firstembodiment of the invention during a first phase E of a cyclic bloodtreatment process.

Table 1 illustrates how the first phase E and a second phase R arerelated to one another. We assume that a first cycle c1 of the processincludes one repetition each of the first and second phases E and Rrespectively. Then follows a second cycle c2, likewise including onerepetition each of the first and second phases E and R, and so on.

The apparatus includes a blood treatment unit D, a pair of fluid pumpsPF1 and PF2 respectively, a pair of blood pumps PB1 and PB2 respectivelyand flow measurement means, which in turn, include first and second flowmeters Q1 and Q2 respectively and a control unit P. Moreover, theapparatus includes first and second blood valve means V1 and V2respectively.

The blood treatment unit D is configured to receive untreated blood froma blood source BS (e.g. represented by a bag containing blood to betreated, or a renal patient), and receive fresh blood treatment fluidoriginating from a fluid source FS (e.g. a bag of dialysis fluid). Theblood treatment unit D is also configured to emit treated blood to atarget vessel BT (e.g. represented by a bag for cleaned blood, or arenal patient), and emit used blood treatment fluid (e.g. into thedrain, or a waste compartment FD). The blood treatment unit D has ablood side and a fluid side that are separated from one another by meansof a semi-permeable membrane structure. For example, this structure maybe represented by a large number of hollow fibers whose walls constitutea respective semi-permeable membrane and which fibers are configured totransport blood. The structure is also configured to allow bloodtreatment fluid to be passed outside said fibers when blood istransported there through. Naturally, the opposite situation is equallywell applicable, i.e. that blood treatment fluid is passed through thefibers and blood is passed on the outside thereof. In any case, bloodtreatment (e.g. dialysis) takes place over each fiber's semi-permeablemembrane. Hence, the overall function of the blood treatment unit D isto receive untreated blood and fresh blood treatment fluid, and emittreated blood and used blood treatment fluid.

The fluid pumps PF1 and PF2 are configured to pass blood treatment fluidthrough the blood treatment unit D. Analogously, the blood pumps PB1 andPB2 are configured to extract untreated blood from the blood source BS,pass extracted blood through the blood treatment unit D and delivertreated blood to the target vessel BT. According to the embodiment ofthe invention illustrated in FIGS. 1 a and 1 b, the fluid pumps PF1 andPF2 are also configured to control the operation of the blood pumps PB1and PB2 via the blood treatment fluid.

The blood valve means V1 and V2 are controlled to be open and closed inan alternating fashion, such that the first blood valve means V1 is openwhen the second blood valve means V2 is closed, and vice versa. Thisresults in a cyclic operation of the apparatus, wherein during the firstphase E untreated blood is extracted from the blood source BS, andduring the second phase R treated blood is delivered to the targetvessel BT.

The flow measurement means Q1, Q2 and P are configured to determine atleast one blood flow parameter BQFI and/or BQFO, which reflects a flowof blood in relation to the blood treatment unit D. For example a firstblood flow parameter BQFI may reflect a flow of blood from the firstblood pump PB1 into the blood treatment unit D, and a second blood flowparameter BQFO may reflect a flow of blood out from the blood treatmentunit D into the second blood pump PB2. In renal care treatment, theseare both critical parameters to monitor. In the following discussion,however, we will focus primarily on the first blood flow parameter BQFI.Namely, after having understood the principles behind how this parameteris determined, it is relatively straightforward to appreciate how thesecond blood flow parameter BQFO is derived according to embodiments ofthe invention.

According to one embodiment of the invention, the control unit P isconfigured to determine the first blood flow parameter BQFI based on adifference between a first amount DMI and a second amount DMO. The firstamount DMI represents a quantity of fresh blood treatment fluid receivedinto the apparatus comprising the blood treatment unit D, and the secondamount DMO represents a quantity of used blood treatment fluid emittedfrom the apparatus. The first and second amounts DMI and DMOrespectively are registered during a first well-defined period T_(a) ofoperation of the apparatus.

Table 1 shows that the first well-defined period T_(a) is equal to theduration of the first phase E. According to the invention, a secondwell-defined period T is also defined, which preferably represents aninterval during which both of the first and second phases E and Rrespectively are completed at least once. Hence, another well-definedperiod T_(b) may be equal to the duration of the second phase R, suchthat T=T_(a)+T_(b). Consequently, the following relationships arelikewise true: T≧T_(a) and T≧T_(b). If the second blood flow parameterBQFO were to be determined, T_(b) would instead have represented thefirst well-defined period. It should also be noted that the duration ofT_(a) may be different from the duration of T_(b), and the cycleduration may vary from cycle to cycle, e.g. between c1 and c2, such thatalso T varies.

In any case, the first blood flow parameter BQFI represents an averageblood flow into the blood treatment unit D during the secondwell-defined period T. Preferably, the first well-defined period (i.e.T_(a) or T_(b)) represents the time required to complete one of thefirst and second phases (i.e. E or R) at least once, and the secondwell-defined period T represents an interval during which both of thefirst and second phases E and R are completed at least once. However, asis apparent from Table 1, the relative order of the first and secondphases E and R during the second well-defined period T is irrelevant.Thus, T may be defined such that the second phase R precedes the firstphase E.

According to the proposed approach, the first amount DMI may be derivedbased on a first fluid flow parameter FQFI that is registered by thefirst flow meter Q1. The first flow meter Q1 is arranged on a conduitreceiving fresh blood treatment fluid into the apparatus. Thus, thefirst flow meter Q1 can be arranged downstream (as shown) or upstream ofthe first fluid pump PF1. Similarly, the second amount DMO may bederived based on a second fluid flow parameter FQFO that is registeredby the second flow meter Q2. The second flow meter Q2 is arranged on aconduit discharging used blood treatment fluid from the apparatus. Thus,the second flow meter Q2 can be arranged upstream (as shown) ordownstream of the second fluid pump PF2.

To derive the first amount DMI during the first well-defined intervalT_(a) (or T_(b) if the second blood flow parameter BQFO is to bedetermined), the control unit P is preferably configured to apply thefollowing strategy.

-   (i) At the start of the interval T_(a), register an initial    accumulated mass (or volume) of blood treatment fluid having been    fed into the apparatus, DMI_(start),-   (ii) during the interval T_(a), update the accumulated mass (or    volume) of blood treatment fluid fed into the apparatus based on the    first fluid flow parameter FQFI,-   (iii) at the end of the interval T_(a), register a final accumulated    mass (or volume) of blood treatment fluid having been fed into the    apparatus, DMI_(end), and-   (iv) after the end of the interval T_(a),    -   calculate DMI=DMI_(end)−DMI_(start).

Analogously, to derive the second amount DMO during the firstwell-defined interval T_(a) (or T_(b) if the second blood flow parameterBQFO is to be determined), the control unit P is preferably configuredto apply the following strategy.

-   (i) At the start of the interval T_(a), register an initial    accumulated mass (or volume) of blood treatment fluid having been    discharged from the apparatus, DMO_(start),-   (ii) during the interval T_(a), update the accumulated mass (or    volume) of blood treatment fluid discharged from the apparatus based    on the second fluid flow parameter FQFO,-   (iii) at the end of the interval T_(a), register a final accumulated    mass (or volume) of blood treatment fluid having been discharged    from the apparatus, DMO_(end), and-   (iv) after the end of the interval T_(a),    -   calculate DMO=DMO_(end)−DMO_(start).

Finally, the control unit P is preferably configured to determine thefirst blood flow parameter BQFI (i.e. the average blood flow into theblood treatment unit D during the second well-defined intervalT=T_(a)+T_(b)) as:

$\begin{matrix}{{BQFI} = \frac{{DMO} - {DMI}}{T}} & \lbrack 1\rbrack\end{matrix}$

If instead the second blood flow parameter BQFO is to be determined(i.e. the average blood flow out from the blood treatment unit D duringthe second well-defined interval T=T_(a)+T_(b)), this parameter may becalculated as:

$\begin{matrix}{{BQFO} = \frac{{DMI} - {DMO}}{T}} & \lbrack 1^{\prime} \rbrack\end{matrix}$

According to embodiments of the invention, each of the blood pumps PB1and PB2 includes a pumping chamber. A flexible member FM1 and FM2 (e.g.in the form of a soft/elastic membrane) separates this pumping chamberinto a first accumulation container B1 and B2 respectively, and a secondaccumulation container F1 and F2 respectively. Each flexible member FM1and FM2 is movable within its pumping chamber so as to vary a volumerelationship between the first and second accumulation containers B1, B2and F1, F2 respectively. Furthermore, each second accumulation containerF1 and F2 is configured to receive an amount of working fluid to act onthe flexible member FM1 and FM2 respectively, and thus pump bloodthrough the first accumulation container B1 and B2 respectively.According to the embodiment of the invention shown in FIGS. 1 a and 1 b,the fluid pumps PF1 and PF2 respectively and the blood pumps PB1 and PB2are arranged relative to one another, such that the blood treatmentfluid constitutes the working fluid for the blood pumps PB1 and PB2.Hence, the fluid pumps PF1 and PF2 control the operation of the bloodpumps PB1 and PB2 via the blood treatment fluid.

The first fluid pump PF1 is configured to draw blood treatment fluid(e.g. dialysis fluid) from the fluid source FS. During the first phase Eof the cyclic blood treatment process illustrated in FIG. 1 a, the firstfluid pump PF1 draws a relatively small flow of blood treatment fluid,and pumps this fluid directly into a fluid side of the blood treatmentunit D via the first flow meter Q1.

During the first phase of the cyclic blood treatment process, the secondfluid pump PF2 is configured to extract/suck fresh blood treatment fluidfrom the second accumulation container F1 of the first blood pump PB1and draw this blood treatment fluid through the fluid side of the bloodtreatment unit D. The operation of the second fluid pump PF2 also causesused blood treatment fluid to be extracted/sucked from the secondaccumulation container F2 of the second blood pump PB2. After passingthe second fluid pump PF2, this blood treatment fluid passes through thesecond flow meter Q2 and is discharged from the apparatus, e.g. into thedrain or the waste compartment FD. The operation of the first and secondfluid pumps PF1 and PF2 during the first phase causes a trans-membraneflow from the blood side to the fluid side of the blood treatment unitD, or vice versa.

The first blood valve means V1 is configured to control the extractionof untreated blood from the blood source BS via a first needle N1.Analogously, the second blood valve means V2 is configured to controlthe delivery of treated blood to the target vessel BT via a secondneedle N2. Of course, in a single-needle implementation the first andsecond blood valve means V1 and V2 are instead both connected to oneneedle, which is attached to a patient's blood system.

In any case, during the first (or blood extraction) phase of the cyclicblood treatment process illustrated in FIG. 1 a, the first blood valvemeans V1 is open and the second blood valve means V2 is closed. As aresult, when the second fluid pump PF2 pulls the fresh blood treatmentfluid out from the second accumulation container F1 of the first bloodpump PB1, untreated blood is extracted from the blood source BS and fedinto the first accumulation container B1 of the first blood pump PB1.Moreover, since the second fluid pump PF2 also draws used bloodtreatment fluid out from the second accumulation container F2 of thesecond blood pump PB2, incoming blood continues into the blood side ofthe blood treatment unit D. Blood located on the blood side of the bloodtreatment unit D is further pulled into the first accumulation containerB2 of the second blood pump PB2. Hence, blood passes through the bloodtreatment unit D, and as a result, this blood is treated by the bloodtreatment fluid passing through the fluid side of the blood treatmentunit D.

FIG. 1 b illustrates the second (or blood delivery) phase of the cyclicblood treatment process. In this phase, the first blood valve means V1is closed while the second blood valve means V2 is open. Preferably, theblood valve means V1 and V2 are controlled via a respective controlsignal c₁ and c₂ generated by a control unit P. In contrast to the firstphase, during the second phase the first fluid pump PF1 draws arelatively large flow of fresh blood treatment fluid from the fluidsource FS. The thus extracted blood treatment fluid continues into thesecond accumulation container F1 of the first blood pump PB1. The entryof fresh blood treatment fluid into the second accumulation container F1of the first blood pump PB1, in turn, causes untreated blood located inthe first accumulation container B1 of the first blood pump PB1 to bepushed through the blood side of the blood treatment unit D.

Moreover, the operation of the first fluid pump PF1 causes fresh bloodtreatment fluid to be extracted/sucked from the fluid source FS. Afterpassing through the first flow meter Q1 this blood treatment fluidcontinues into the fluid side of the blood treatment unit D. Subsequentto passing the blood treatment unit D, the blood treatment fluidcontinues into the second accumulation container F2 of the second bloodpump PB2. This, in turn, causes blood located in the first accumulationcontainer B2 of the second blood pump PB2 to be ejected into the targetvessel BT via the second blood valve means V2 and the second needle N2.

Preferably, during the second phase R of the cyclic blood treatmentprocess, the second fluid pump PF2 is also operated to some extent. Thiscauses a fraction of the used blood treatment fluid to exit directlyfrom the blood treatment unit D and be discharged after passing throughthe second flow meter Q2 (i.e. without being temporarily stored in thesecond blood pump PB2). The operation of the first and second fluidpumps PF1 and PF2 during the second phase causes a trans-membrane flowfrom blood side to the fluid side of the blood treatment unit D, or viceversa. Thus, by controlling the first and second fluid pumps PF1 and PF2an amount of fluid drawn from the blood passing through the bloodtreatment unit D can be adjusted.

Preferably, the control unit P is configured to control the operation ofthe fluid pumps PF1 and PF2 via first and second motoric signals m1 andm2 respectively.

Moreover, it is advantageous if the control unit P is configured toregister pressure parameters (not shown) on the conduit passing thefresh blood treatment fluid into the apparatus, as well as on theconduit discharging used blood treatment fluid from the apparatus.Namely, in response to such pressure measurements, the control unit Pmay control the valve means V1 and V2 and the fluid pumps PF1 and PF2such that the apparatus operates according to the cyclic process asoutlined above. Specifically, the control unit P may use theabove-mentioned pressure parameters to determine appropriate transitionsbetween the first and second phases, and thus control the valve meansV1, V2 and the fluid pumps PF1, PF2 as described above. Preferably, thecontrol unit P includes, or is associated with; a memory means M storingcomputer software for controlling the control unit P to effect theabove-described procedure.

However, prior to initiating said cyclic process, so-called priming isnormally required. This procedure involves filling and rinsing theapparatus and may be effected as follows. The fluid circuit is filledwith fresh blood treatment fluid, such that superfluous fluid rinses thecircuit from the fluid source FS. The filling of the fluid causes anyair in the dialysis fluid circuit to be pushed back out from theapparatus, e.g. into the waste compartment FD. Correspondingly, thefirst needle N1 may be connected to a saline solution (or otherappropriate fluid) to fill and rinse, and thus eliminate any gas bubblesin the blood circuit.

FIGS. 2 a and 2 b show block diagrams over a blood treatment apparatusaccording to a second embodiment of the invention during the first andsecond phases E and R respectively of the proposed cyclic treatmentprocess. In FIGS. 2 a and 2 b all units and components having referencesigns, which also occur in FIGS. 1 a and 1 b designate the same unitsand components as those described above with reference to FIGS. 1 a and1 b.

The second embodiment differs from the first embodiment of the inventionin that the blood pumps PB1 and PB2 are not cross-connected relative tothe inlet and outlet for receiving fresh blood treatment fluid anddischarging used blood treatment fluid respectively. Instead, first andsecond additional fluid pumps PF3 and PF4 respectively are included tocontrol the blood pumps PB1 and PB2 as desired (i.e. cause the flexiblemembers FM1 and FM2 to reach their respective end positions essentiallysimultaneously).

The control unit P is configured to control the first additional fluidpump PF3 via a third motoric signal m3, and control the secondadditional fluid pump PF4 via a fourth motoric signal m4. Specifically,during the first phase E, this involves extracting/sucking used bloodtreatment fluid from the second accumulation container F1 of the firstblood pump PB1 and extracting/sucking fresh blood treatment fluid fromthe second accumulation container F2 of the second blood pump PB2.During the second phase R, however, the control unit P is configured tooperate the first and second additional fluid pumps PF3 and PF4 in theopposite direction, i.e. such that fresh blood treatment fluid is pumpedinto the second accumulation container F2 of the second blood pump PB2and used blood treatment fluid is pumped into the second accumulationcontainer F1 of the first blood pump PB1.

FIGS. 3 a and 3 b show block diagrams over a blood treatment apparatusaccording to a third embodiment of the invention during the first andsecond phases E and R respectively of the proposed cyclic treatmentprocess. In FIGS. 3 a and 3 b all units and components having referencesigns, which also occur in FIGS. 1 a, 1 b, 2 a and 2 b designate thesame units and components as those described above with reference toFIGS. 1 a, 1 b, 2 a and 2 b.

The third embodiment differs from the first and second embodiments ofthe invention primarily in that the blood pumps PB1 and PB2 arecontrolled via a working fluid, which is separated from the bloodtreatment fluid. To accomplish this, in the design shown in FIGS. 3 aand 3 b the second accumulation container F1 of the first blood pump PB1is connected to a first working-fluid container W1, and the secondaccumulation container F2 of the second blood pump PB2 is connected to asecond working-fluid container W2. A respective additional fluid pumpPF3 and PF4 is arranged on a fluid conduit between each of theworking-fluid containers W1 and W2 and the blood pumps PB1 and PB2.Analogous to the embodiment illustrated in FIGS. 2 a and 2 b, however,the first and second blood pumps PB1 and PB2 are controlled by the firstand second additional fluid pumps PF4 and PF3 respectively. Of course,according to the invention, instead of being separated from one another,the containers W1 and W2 may equally well be represented by a commonsource of working fluid. Moreover, the working fluid may be any kind ofincompressible medium.

In any case, according to this embodiment of the invention, the controlunit P is configured to determine the first blood flow parameter BQFI onthe further basis of a respective stroke volume V_(B1) and V_(B2) of theblood pumps PB1 and PB2. Namely, in this case, the difference betweenthe first and second amounts of blood treatment fluid DMO and DMIexclusively represents an ultrafiltration parameter between the bloodand fluid sides of the blood treatment unit D. Hence, the control unit Pis here configured to determine the first blood flow parameter BQFI as:

$\begin{matrix}{{BQFI} = \frac{{DMO} - {DMI} + V_{B\; 1} + V_{B\; 2}}{T}} & \lbrack 2\rbrack\end{matrix}$where T=T_(a)+T_(b)where DMO and DMI are measured during a first well defined period T_(a).

FIGS. 4 a and 4 b show block diagrams over a blood treatment apparatusaccording to a fourth embodiment of the invention during the first andsecond phases E and R respectively of the proposed cyclic treatmentprocess. In FIGS. 4 a and 4 b all units and components having referencesigns, which also occur in FIGS. 1 a, 1 b, 2 a, 2 b, 3 a and 3 bdesignate the same units and components as those described above withreference to FIGS. 1 a, 1 b, 2 a, 2 b, 3 a and 3 b.

Similar to the third embodiment, the fourth embodiment differs from thefirst, second embodiments of the invention in that the blood pumps PB1and PB2 are controlled by other means than via the blood treatmentfluid. However, in contrast to the third embodiment, the designillustrated in FIGS. 4 a and 4 b includes blood pumps PB1 and PB2 ofpiston type. Consequently, the control unit P is configured to: controlthe first blood pump PB1 via a first piston control signal k1 andcontrol the second blood pump PB2 via a second piston control signal k2.

Piston pumps are advantageous, since by keeping track of the respectivepiston position, this design renders it possible to determine a pumpedvolume at arbitrary pump positions, i.e. not only at the end positions.Keeping track of the respective piston pump may be done e.g. by countingsteps of a stepping motor driving the piston and thereby determining theaccumulated blood volume extracted or returned by the pump. Hence, eachstroke volume V_(B1) and V_(B2) of the blood pumps PB1 and PB2respectively is a variable parameter.

Nevertheless, in further analogy to the third embodiment of theinvention, the difference between the first and second amounts of bloodtreatment fluid DMI and DMO exclusively represents an ultrafiltrationparameter between the blood and the fluid sides of the blood treatmentunit D, and the first blood flow parameter BQFI is further based on thestroke volumes V_(B1) and V_(B2) of the blood pumps PB1 and PB2respectively. We can thus use the expression [2] above to determine thefirst blood flow parameter BQFI.

In order to determine the second blood flow parameter BQFO reflectingthe average flow of blood out from the blood treatment unit D, the firstand second amounts of blood treatment fluid DMI and DMO are insteaddetermined during the second phase R of the cyclic process. Hence, thefirst well-defined period of operation is given by T_(b). Therefore, todetermine the second blood flow parameter BQFO, the control unit P ispreferably configured to apply strategies as described above under thefirst and second sets of steps (i)-(iv) with reference to the expression[1], however where the measurements are performed during the intervalT_(b) (as opposed to T_(a)). Analogously, the expression [2] isapplicable to the embodiments described in FIGS. 3 a/3 b and 4 a/4 b fordetermining second blood flow parameter BQFO.

Generally, in designs where the stroke volumes V_(B1) and V_(B2) of theblood pumps PB1 and PB2 respectively are known, it is possible todetermine first and second blood flow parameters BQFI_(a) respectiveBQFO_(a) and BQFI_(b) respective BQFO_(b) after each phase E and Rrespectively of the cyclic process.

Specifically, after completion of the first phase E, the first bloodflow parameter BQFI_(a) may be calculated as:

${BQFI}_{a} = \frac{{DMO} - {DMI} + V_{B\; 2}}{T_{a}}$and the second blood flow parameter BQFO_(a) may be calculated as:

${BQFO}_{a} = {\frac{V_{B\; 2}}{T_{a}}.}$Similarly, after completion of the second phase R, the first blood flowparameter BQFI_(b) may be calculated as:

${BQFI}_{b} = \frac{V_{B\; 1}}{T_{b}}$and the second blood flow parameter BQFO_(b) may be calculated as:

${BQFO}_{b} = {\frac{{DMI} - {DMO} + V_{B\; 1}}{T_{b}}.}$

Additionally, provided that a respective flow measuring means (notshown) is included in the embodiments illustrated in FIGS. 1 a/1 b, 2a/2 b or 3 a/3 b, which flow meters are configured to register arespective fluid flow QPB1 and QPB2 out from and into, respectively, thefirst and second blood pumps PB1 and PB2, more specifically out from andinto the first and second accumulation containers F1 and F2, it ispossible to determine instantaneous blood flow parameters in relation tothe blood treatment unit D.

Particularly, during the first phase E, a first instantaneous blood flowparameter BQFI_(inst-a) reflecting the blood flow into the bloodtreatment unit D in the embodiment shown in FIGS. 1 a and 2 a may becalculated as:BQFI _(inst-a) =FQFO−FQFI−QPB1For the embodiment shown in FIG. 3 a it may be calculated as:BQFI _(inst-a) =FQFO−FQFI+QPB2and a second instantaneous blood flow parameter BQFO_(inst-a) reflectingthe blood flow out from the blood treatment unit D may be calculated as:BQFO _(inst-a) =QPB2.

Furthermore, during the second phase R, the first instantaneous bloodflow parameter BQFI_(inst-b) reflecting the blood flow into the bloodtreatment unit D may be calculated as:BQFI _(inst-b) =QPB1and the second instantaneous blood flow parameter BQFO_(inst-b)reflecting the blood flow out from the blood treatment unit D may forthe embodiment shown in FIGS. 1 b and 2 b be calculated as:BQFO _(inst-b) =FQFI−FQFO−QPB2

For the embodiment shown in FIG. 3 b it may be calculated as:BQFO _(inst-b) =FQFI−FQFO+QPB1

In an alternative embodiment of the arrangements shown in FIGS. 1 a, 1b, 2 a, 2 b, 3 a and 3 b the flow measuring means described above,possibly in cooperation with the control unit P, are configured toaccumulate a mass (or volume) of treatment fluid or working fluid fedinto, or discharged from, the respective second accumulation containerF1, F2. This design renders it possible to determine a pumped mass (orvolume) at arbitrary positions of the respective flexible member FM1,FM2, i.e. not only at the end positions. Hence, the stroke volume V_(B1)and V_(B2) of the blood pumps PB1 and PB2 is a variable parameter andthus selectable in the same way as described in connection with thepiston pumps disclosed in FIGS. 4 a, 4 b. Consequently, the control unitP is configured to control the first and the second blood pump PB1; PB2respectively via the relevant motoric control signals m1, m2, m3 and m4such that when a certain accumulated volume is reached, the relevantcontrol signal controls the relevant fluid pumps PF1, PF2; PF3, PF4 topass working fluid in a reversed direction with respect to the secondaccumulation containers F1, F2 to effect a transition between e.g. thefirst and the second phase of operation E and R respectively. Theability to select the stroke volume is advantageous e.g. for smallpatients, where a too large stroke volume in some cases may causedisturbances in the cardiovascular system, either short term or longterm. On the other hand a large stroke volume enables a higher averageblood flow rate through the blood treatment unit, and thus may improvethe efficiency of the treatment of the blood.

An alternative embodiment of the blood treatment apparatus, initiallydescribed, comprises a control unit P and a measuring means configuredto emit a feedback signal indicative of the amount of working fluidreceived into, or discharged from at least one of the secondaccumulation containers F1, F2 whereby the pumped volume of workingfluid is determined by the control unit P at an arbitrary position ofthe flexible member FM1, FM2.

The measuring means may be configured to register a working fluid flowQPB1, QPB2 or a time with a constant fluid flow QPB1, QPB2 and thecontrol unit P may be configured to determine an accumulated amount ofworking fluid received into, or discharged from at least one of thesecond accumulation containers F1, F2.

The flow measuring means may e.g. be constituted by a device comprisinga piston pump with a controlled infusion of fluid, a device comprising apair of scales or a device comprising a means for flow restriction and ameans for measuring pressure drop over the means for flow restriction.

As described above the control unit P may be configured to register apressure parameter related to the working fluid received into, ordischarged from at least one of the second accumulation containers F1,F2. In one embodiment this pressure parameter is used to determine anend position of the flexible member FM1, FM2. The end position may beutilized to determine an initial start volume equal to zero whenchanging between phases E, R and starting to accumulate a mass or volumeof working fluid pumped into or discharged from at least on of thesecond accumulation containers F1, F2.

According to one embodiment the blood treatment apparatus initiallydescribed further comprises a flow measurement means Q1, Q2, Pconfigured to determine at least one blood flow parameter BQFI, BQFOreflecting a flow of blood in relation to the blood treatment unit D.The control unit P forming part of the flow measurement means isconfigured to determine the at least one blood flow parameter BQFI, BQFObased on a difference between a first amount DMI of fresh bloodtreatment fluid received into the apparatus, and a second amount DMO ofused blood treatment fluid emitted from the apparatus, the first andsecond amounts DMI, DMO being registered during the first well-definedperiod of operation T_(a), T_(b) of the apparatus, and the at least oneblood flow parameter BQFI, BQFO representing an average blood flowduring the second well-defined period T.

To sum up, we will now describe the proposed blood-flow-measurementmethod with reference to the flow diagram in FIG. 5. Here, we presumethat the blood treatment apparatus includes: a blood treatment unitconfigured to receive untreated blood and fresh blood treatment fluid,and emit treated blood and used blood treatment fluid. A pair of fluidpumps is configured to pass blood treatment fluid through the bloodtreatment unit and a pair of blood pumps is configured to extractuntreated blood from a blood source, pass extracted blood through theblood treatment unit and deliver treated blood to a target vessel. Forreasons of clarity, we also presume that the first well-defined periodis represented by T_(a) (i.e. that T_(b) is subsequent to T_(a) withinT). However, of course, the first well-defined period may equally wellbe represented by T_(b). As discussed above, in such a case the firstand second well-defined periods instead end simultaneously.

A first step 510 checks whether or not a start criterion has beenfulfilled, and if not, the procedure loops back and stays in step 510.If the start criterion is found to be fulfilled, a step 520 follows.Technically, the start criterion may correspond to any type of event.However, preferably the start criterion is deemed fulfilled inconnection with transitioning between the above-mentioned first andsecond phases of operation E and R respectively. Such a transition, inturn, may be detected via various pressure measurements, and/or inresponse to closing or opening one or more of the first and second bloodvalve means V1 and V2. Alternatively such a transition may be initiatedarbitrarily by means of volume measurements or fluid measurements asdescribed above.

Step 520 starts time measurement to determine the duration of the secondwell-defined period of operation of the apparatus. Thereafter, a step530 registers a first amount of fresh blood treatment fluid receivedinto the apparatus comprising the blood treatment unit. Preferably, thisis effected accumulatively as outlined above with reference to the firstset of steps (i)-(iv) and the expression [1]. In parallel with step 530,a step 540 registers a second amount of used blood treatment fluidemitted from the apparatus. Preferably, this also is effectedaccumulatively as outlined above with reference to the second set ofsteps (i)-(iv) and the expression [1].

After each updating of the accumulated first and second amounts in steps530 and 540, a step 550 checks whether or not an end criterion for thefirst well-defined period is fulfilled, and if so, a step 560 follows.Otherwise, the procedure loops back to steps 530 and 540 for continuedupdating of the first and second amounts. Step 560 checks whether or notan end criterion for the second well-defined period is fulfilled, and ifso, a step 570 follows. Otherwise, the procedure loops back and stays instep 560.

Step 570 stops the time measurement initiated in step 520, i.e. definesthe extension of the second well-defined period of operation of theapparatus. Subsequently, a step 580 determines the blood flow parameterbased on a difference between the first and second amounts and theduration of the second well-defined period. The blood flow parameterthus expresses an average blood flow in relation to the blood treatmentunit during the second well-defined period.

Thereafter, the procedure loops back to step 510, and preferably, theprocedure iterates as described above until the treatment is finalized.

All of the steps, as well as any sub-sequence of steps, described withreference to FIG. 5, above may be controlled by means of a programmedcomputer apparatus. Moreover, although the embodiments of the inventiondescribed above with reference to the drawings comprise computerapparatus and processes performed in computer apparatus, the inventionthus also extends to computer programs, particularly computer programson or in a carrier, adapted for putting the invention into practice. Theprogram may be in the form of source code, object code, a codeintermediate source and object code such as in partially compiled form,or in any other form suitable for use in the implementation of theprocedure according to the invention. The program may either be a partof an operating system, or be a separate application. The carrier may beany entity or device capable of carrying the program. For example, thecarrier may comprise a storage medium, such as a Flash memory, a ROM(Read Only Memory), for example a DVD (Digital Video/Versatile Disk), aCD (Compact Disc), an EPROM (Erasable Programmable Read-Only Memory), anEEPROM (Electrically Erasable Programmable Read-Only Memory), or amagnetic recording medium, for example a floppy disc or hard disc.Further, the carrier may be a transmissible carrier such as anelectrical or optical signal which may be conveyed via electrical oroptical cable or by radio or by other means. When the program isembodied in a signal which may be conveyed directly by a cable or otherdevice or means, the carrier may be constituted by such cable or deviceor means. Alternatively, the carrier may be an integrated circuit inwhich the program is embedded, the integrated circuit being adapted forperforming, or for use in the performance of, the relevant procedures.

In an alternative flow measurement method the following steps arecomprised; registering the amount of the working fluid received into, ordischarged from at least one of the second accumulation containers F1,F2 of at least one of the blood pumps PB1, PB2, emitting a feedbacksignal being indicative of the accumulated amount of working fluidreceived in the second accumulation container F1, F2, based on thefeedback signal, determining the pumped volume at an arbitrary positionof the flexible member FM1, FM2, at a certain volume reversing thedirection of the working fluid with respect to the second accumulationcontainer F1; F2 and thereby effecting the arbitrary transition betweene.g. a first and a second phase E, R.

The amount of working fluid may be registered by a means for measuringof the working fluid flow QPB1, QPB2. Alternatively the amount ofworking fluid may be registered by a means for measuring a time duranceof a constant flow of working fluid QPB1, QPB2.

One embodiment of the method comprises pumping the treatment fluid bymeans of the fluid pumps PF1, PF2 and controlling operation of the bloodpumps PB1, PB2 via the pumped blood treatment fluid. An alternativeembodiment of the method comprises controlling the blood pumps PB1, PB2via a working fluid which is fluidly separated from the blood treatmentfluid. However, also in this embodiment the working fluid as such may beconstituted by the blood treatment fluid.

In an alternative embodiment of the method one phase shift, e.g.transition between the return phase, R, and extraction phase, E, iseffectuated at an end position of the flexible member FM1, FM2 and thetransition between the extraction phase, E, and the return phase, R, iseffectuated at an arbitrary position of the flexible membrane FM1, FM2.The end position of the membrane may be determined by the control unit,P, based on registered pressure parameters as described above.

In one embodiment of the initially described method making use of aselectable stroke volume V_(B1) and V_(B2) by arbitrary transitionbetween the first and second phase E, R or between the second and firstphase R, E the following steps are comprised: during a firstwell-defined period of operation T_(a); T_(b) of the apparatus a firstamount DMI of fresh blood treatment fluid received into the apparatus isregistered as well as a second amount DMO of used blood treatment fluidemitted from the apparatus. After expiry of a second well-defined periodT, the at least one blood flow parameter BQFI, BQFO is determined as anaverage blood flow during the second well-defined period T based on adifference between the first and second amounts DMI; DMO.

In this specification, the wording that: “a fluid pump is arranged in aconduit” shall be understood to also encompass arrangements wherein thepump is configured to operate on a fluid passing through the conduit byother means than having the pump actually included in the conduit, suchas hose pumps manipulating the exterior of a fluid conduit.

The reference to any prior art in this specification is not, and shouldnot be taken as, an acknowledgement or any suggestion that thereferenced prior art forms part of the common general knowledge inAustralia, or in any other country.

The term “comprises/comprising” when used in this specification is takento specify the presence of stated features, integers, steps orcomponents. However, the term does not preclude the presence or additionof one or more additional features, integers, steps or components orgroups thereof.

The invention is not restricted to the described embodiments in thefigures, but may be varied freely within the scope of the claims.

The invention claimed is:
 1. A blood treatment apparatus comprising: ablood treatment unit configured to receive untreated blood and freshblood treatment fluid, and emit treated blood and used blood treatmentfluid, a pair of fluid pumps configured to pass the blood treatmentfluid through the blood treatment unit, a pair of blood pumps configuredto extract the untreated blood from a blood source, pass the extracteduntreated blood through the blood treatment unit and deliver the emittedtreated blood to a target vessel, wherein each blood pump includes apump chamber and a flexible member separating the pumping chamber into ablood accumulating container and a working fluid accumulating container,where the flexible member is configured to flex to vary a volumerelationship between the blood and the working fluid accumulationcontainers; a control unit, and a measuring device configured to emit afeedback signal indicative of the amount of working fluid received intoor discharged from at least one of the working fluid accumulationcontainers whereby a mass or volume of the working fluid is determinedby the control unit at an arbitrary position of the flexible member. 2.The blood treatment apparatus according to claim 1 wherein the measuringdevice is configured to register a working fluid flow and the feedbacksignal is indicative of the working fluid flow.
 3. The blood treatmentapparatus according to claim 1 wherein the measuring device isconfigured to register a duration of a constant working fluid flow andthe feedback signal is indicative of the duration.
 4. The bloodtreatment apparatus according to claim 1 wherein the pair of fluid pumpsare configured to control the operation of the blood pumps via the bloodtreatment fluid acting as the working fluid.
 5. The blood treatmentapparatus according to claim 1, further comprising a controllercontrolling the blood pumps via the working fluid, wherein the workingfluid is separated from the blood treatment fluid.
 6. The bloodtreatment apparatus according to claim 1, wherein the control unit isconfigured to register a pressure parameter related to the working fluidreceived into or discharged from at least one of the working fluidaccumulation containers, and the control unit is configured to determinean end position of the flexible member based on the pressure parameter.7. The blood treatment apparatus according to claim 1, furthercomprising a flow measurement device configured to determine at leastone blood flow parameter indicative of the flow of the blood through theblood treatment unit, and the flow measurement device is configured todetermine the at least one blood flow parameter based on a differencebetween: a first amount of fresh blood treatment fluid received into theapparatus, and a second amount of used blood treatment fluid emittedfrom the apparatus, the first and second amounts being registered duringa first period of operation of the blood treatment apparatus, and the atleast one blood flow parameter representing an average blood flowthrough the blood treatment unit during a second period of operation ofthe blood treatment apparatus.
 8. A method for transitioning between afirst and a second phase in a blood treatment apparatus comprising:receiving blood and blood treatment fluid by a blood treatment unit anddischarging blood and blood treatment fluid from the blood treatmentunit, wherein the blood treatment unit treats the blood before thedischarge, a pair of fluid pumps pumping the blood treatment fluidthrough the blood treatment unit, a pair of blood pumps pumping theblood from a blood source, and through the blood treatment unit, andpumping the discharged blood to a target vessel, wherein each blood pumpincludes a pump chamber and a flexible member separating the pumpingchamber into a blood accumulating container and a working fluidaccumulating container and wherein the flexible member is configured toflex to vary a volume relationship between the blood and the workingfluid accumulation containers; registering the amount of the workingfluid received into or discharged from at least one of the working fluidaccumulation containers by at least one of the blood pumps, andgenerating a feedback signal indicative of the accumulated amount of theworking fluid received in or discharged from the at least one of theworking fluid accumulation containers; based on the feedback signal,determining the pumped mass or volume of the working fluid at anarbitrary position of the flexible member; at a predetermined pumpedvolume or mass of the working fluid, reversing the flow direction of theworking fluid with respect to the working fluid accumulation containerand thereby effecting the transition between the first and the secondphase.
 9. The method according to claim 8 wherein the registering of theamount of the working fluid comprises measuring the flow of the workingfluid.
 10. The method according to claim 8 wherein the registering ofthe amount of working fluid comprises registering of a duration in timeof a constant working fluid flow.
 11. The method according to claim 8wherein the working fluid includes the treatment fluid and the methodfurther comprising pumping the treatment fluid by the fluid pumps andcontrolling the blood pumps via the pumped blood treatment fluid. 12.The method according to claim 11, comprising controlling the blood pumpsvia a working fluid separated from the blood treatment fluid.
 13. Themethod according to claim 8, comprising: registering a pressureparameter related to the pumped working fluid, and determining an endposition of the flex of the flexible member based on the pressureparameter.
 14. The method according to claim 8 wherein, during a firstperiod of operation of the apparatus, the steps performed include:registering a first amount of the blood treatment fluid received intothe apparatus, registering a second amount of the blood treatment fluiddischarged from the apparatus, and after expiry of a second period,determining, based on a difference between the first and second amounts,an average blood flow during the second period.
 15. A blood treatmentapparatus comprising: a blood treatment unit having a blood passage anda treatment fluid passage; a fluid pump connectable to the fluid passageand configured to pump treatment fluid through the treatment fluidpassage; a working fluid pump configured to pump a working fluid in orout of a working fluid accumulation chamber; blood pumps eachconnectable to the blood passage and configured to move blood throughthe blood passage; wherein at least one of the blood pumps includes apumping chamber containing a blood accumulating container, the workingfluid accumulating container and a flexible membrane separating theblood and fluid accumulating containers, and a control unit receiving afeedback signal indicative of an amount of working fluid being moving inor out of the working fluid accumulating container, wherein the controlunit controls the working fluid pump based on the feedback signal. 16.The blood treatment apparatus in claim 15 wherein the amount isdetermined as the flexible membrane flexes in the pumping chamber. 17.The blood treatment apparatus in claim 15, wherein the fluid pump andthe working fluid pump are the same pump.